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Tornier Flex
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref MWE003Model 08858251028016TZ
Identity
- Trade Name
- Tornier Flex Shoulder System EUDAMEDTornier Flex FDA UDI
- Generic Name
- Orthopaedic instrument surgical connector FDA UDI
- Device Name
- TORNIER FLEX SHOULDER SYSTEM INSTRUMENTATION - TRIALING INSTRUMENTATION - CLASS IIA - NON STERILE EUDAMEDTray Trial Screw FDA UDI
- Model / Reference
- MWE003 EUDAMEDFDA UDI08858251028016TZ EUDAMED
- Description
- Tray Trial Screw FDA UDI
Identifiers
- Catalog Number
- MWE003 FDA UDI
- Primary DI / UDI-DI
- 03700386972874 EUDAMEDFDA UDI
- Basic UDI-DI
- 08858251028016TZ EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic instrument surgical connector FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic instrument surgical connector
Tornier Flex by Tornier, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic instrument surgical connector.
- Surgical Instrument — Jeil Medical Corporation · Class I
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- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
- Pilot Spinal System — Life Spine, Inc. · Class II
- MIS Curved Rod, Ø5.5 x 85mm — Captiva Spine · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Tornier, Inc.
Sources (2)
- FDA UDI 29425693-9fe7-420c-a321-76d129c20a2f 35 fields · synced Oct 8, 2026
- EUDAMED 656548a8-c5de-443c-958e-880d920d0756 61 fields · synced Oct 8, 2026